Film-form preparation and method for producing the same

Patent metadata

Field	Value
Publication number	US-9724309-B2
Application number	US-201113073022-A
Country	US
Kind code	B2
Filing date	Mar 28, 2011
Priority date	Mar 30, 2010
Publication date	Aug 8, 2017
Grant date	Aug 8, 2017

Abstract

The present invention provides a film-form preparation having a rapid dissolution profile in the mouth and sufficient film strength, and also having excellent appearance and feel. More specifically, the present invention provides a film-form preparation including: a water-soluble and a polar organic solvent-soluble edible polymer; and polar organic solvent-insoluble drug particles.

First claim

The invention claimed is:

1. A film-form preparation comprising:
a water-soluble and polar organic solvent-soluble edible polymer; and
polar organic solvent-insoluble drug particles,
wherein said polar organic solvent-insoluble drug particles are contained in a particulate state within the film-form preparation,
wherein a particle size of the drug particles is 0.1 to 60 μm, and
wherein the content of the drug particles is 0.1 to 60 wt % of the total content of solids contained in the film-form preparation.

2. The film-form preparation according to claim 1 , wherein the edible polymer is a solid at normal temperatures.

3. The film-form preparation according to claim 1 , wherein the edible polymer is polyvinyl pyrrolidone and/or hydroxypropyl cellulose.

4. The film-form preparation according to claim 3 , wherein a molecular weight of the polyvinyl pyrrolidone ranges from 2,500 to 3,000,000.

5. The film-form preparation according to claim 3 , wherein a molecular weight of the hydroxypropyl cellulose ranges from 10,000 to 1,150,000.

6. The film-form preparation according to claim 3 , wherein the hydroxypropyl cellulose has a hydroxypropoxy group-substitution degree of 50 to 100%.

7. The film-form preparation according to claim 1 , wherein a solubility parameter of the polar organic solvent is not less than 9.7.

8. A method for producing a film-form preparation including a water-soluble and polar organic solvent-soluble edible polymer and polar organic solvent-insoluble drug particles, and the method comprising:
preparing a liquid dispersion of a drug containing the edible polymer, the drug particles, and a polar organic solvent;
forming the liquid dispersion of the drug into a thin layer; and
drying the thin layer,
wherein the particle size of the drug particles is 0.1 to 60 μm.

Assignees

• Asari Daisuke
• Hori Mitsuhiko
• Shishido takuya
• Nitto Denko Corp

Inventors

• Asari Daisuke
• Hori Mitsuhiko
• Shishido takuya

Classifications

• A61K47/32

  Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers {, poly(meth)acrylates, or polyvinyl pyrrolidone} · CPC title

• A61K8/0241

  Containing particulates characterized by their shape and/or structure (see also A61K8/04, A61K8/11, and A61K8/14, further aspects are classified in A61K2800/40 and subcodes) · CPC title

• A61K9/0056

  Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals · CPC title

• A61K9/7007 Primary

  Drug-containing films, membranes or sheets (A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence) · CPC title

• A61P11/08

  Bronchodilators · CPC title